MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for SALLE G32773 manufactured by Cook, Inc..
[79064029]
Patient Sequence No: 1, Text Type: N, H10
[79064030]
The white connector on the salle stent was not working properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6685796 |
| MDR Report Key | 6685796 |
| Date Received | 2017-07-05 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-06-16 |
| Report Date | 2017-06-16 |
| Date Reported to FDA | 2017-06-16 |
| Date Reported to Mfgr | 2017-06-16 |
| Date Added to Maude | 2017-07-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SALLE |
| Generic Name | CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2017-07-05 |
| Model Number | G32773 |
| Catalog Number | G32773 |
| Lot Number | 78939187 |
| ID Number | SIPSF-040018-59 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-05 |